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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9700A RECEIVER UNIT

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NIHON KOHDEN CORPORATION ORG-9700A RECEIVER UNIT Back to Search Results
Model Number ORG-9700A
Device Problems Device Alarm System (1012); Device Issue (2379); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/08/2016
Event Type  malfunction  
Manufacturer Narrative
The customer reported the org has an error light. They tried to initialize the device, but the error code continued. The issue was discovered when the customer attempted to transfer the patient. The customer was advised the org is obsolete and may not be repairable. Nihon kohden continues to investigate the reported event. Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803. 56 when additional information becomes available.
 
Event Description
The customer reported the org has an error light. They tried to initialize the device, but the error code continued. The issue was discovered when the customer attempted to transfer the patient.
 
Manufacturer Narrative
Manufacturer narrative: the customer reported the org has an error light. They tried to initialize the device, but the error code continued. The issue was discovered when the customer attempted to transfer the patient. The customer was advised the org is obsolete and may not be repairable. Device was sent in and evaluated. The reported complaint was confirmed. The mother board was changed to fix this issue. The rssi levels were tested prior to shipping. All receivers were working correctly. Device was repaired and returned. Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803. 56 if additional information becomes available.
 
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Brand NameORG-9700A
Type of DeviceRECEIVER UNIT
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, japan 161-8 560
JA 161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: shama mooman
gunma 370-2 314
JA 370-2314
Manufacturer Contact
shama mooman
safety mgmt dept, quality mgmt
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
2687488
MDR Report Key5780671
MDR Text Key49831174
Report Number8030229-2016-00298
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 07/08/2016,06/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9700A
Device Catalogue NumberMU-970RA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/08/2016
Distributor Facility Aware Date06/08/2016
Device Age121 MO
Event Location Hospital
Date Report to Manufacturer07/08/2016
Date Manufacturer Received07/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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